Device Recall Maquet Flowi

  • Model / Serial
    Model numbers: C20, C30 and C40 (Only Model # C20 for US)  Part numbers: 66 77 200 (US Only), 66 77 300 and 66 77 400  Serial numbers (2743, 2852, 2854, 2855, 2856, 2858
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide in the states of CA, NY, and OR
  • Product Description
    Flow-i Anesthesia System || Product Usage: || The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • Manufacturer Parent Company (2017)
  • Source
    USFDA